Range of motion device

ABSTRACT

A device for moving a knee joint in a body of a patient is provided. The device includes a first arm member coupled to a first leg support configured to support an upper portion of a leg of the patient, a second arm member coupled to a second leg support configured to support at least one of a lower portion of a leg and a foot of the patient, and a control assembly operatively connected to the first and second arm members and configured to selectively move the second arm member relative to the first arm member. The control assembly includes a first motorized drive assembly coupled to the first and second arm members and operable to drive movement of the second arm member relative to the first arm member and a second motorized drive assembly coupled to the first and second arm members and operable to drive movement of the second arm member relative to the first arm member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation application of U.S. patentapplication Ser. No. 14/454,442 filed on Aug. 7, 2014, which is acontinuation of U.S. patent application Ser. No. 13/494,103, which is acontinuation of U.S. patent application Ser. No. 13/151,962 filed onJun. 2, 2011, which is a continuation application of U.S. patentapplication Ser. No. 12/272,436 filed on Nov. 17, 2008, which is aContinuation of U.S. patent application Ser. No. 11/533,839 filed onSep. 21, 2006, which is a Continuation-In-Part of U.S. patentapplication Ser. No. 10/795,892 filed on Mar. 8, 2004, which is aContinuation-In-Part of U.S. patent application Ser. No. 11/261,424filed on Oct. 28, 2005. The contents of each of the above-identifiedapplications are herein incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to an adjustable orthosis for stretchingtissue in the human body. In particular, the present invention relatesto an adjustable orthosis which can be used for stretching tissue suchas ligaments, tendons or muscles around a joint during flexion orextension of the joint.

BACKGROUND OF THE INVENTION

In a joint, the range of motion depends upon the anatomy of that jointand on the particular genetics of each individual. Typically, jointsmove in two directions, flexion and extension. Flexion is to bend thejoint and extension is to straighten the joint; however, in theorthopedic convention some joints only flex. For example, the ankle hasdorsiflexion and plantarflexion. Other joints not only flex and extend,they rotate. For example, the elbow joint has supination and pronation,which is rotation of the hand about the longitudinal axis of the forearmplacing the palm up or the palm down.

When a joint is injured either by trauma or by surgery, scar tissue canform, often resulting in flexion or extension contractures. Suchconditions can limit the range of motion of the joint, limiting flexion(in the case of an extension contracture) or extension (in the case of aflexion contracture) of the injured joint. It is often possible tocorrect this condition by use of a range-of-motion (ROM) orthosis.

ROM orthoses are devices commonly used during physical rehabilitativetherapy to increase the range-of-motion over which the patient can flexor extend the joint. Commercially available ROM orthoses are typicallyattached on opposite members of the joint and apply a torque to rotatethe joint in opposition to the contraction. The force is graduallyincreased to increase the working range or angle of joint motion.Exemplary orthoses include U.S. Pat. No. 6,599,263, entitled “ShoulderOrthosis;” U.S. Pat. No. 6,113,562, entitled “Shoulder Orthosis;” U.S.Pat. No. 5,848,979, entitled “Orthosis;” U.S. Pat. No. 5,685,830,entitled “Adjustable Orthosis Having One-Piece Connector Section forFlexing;” U.S. Pat. No. 5,611,764, entitled “Method of Increasing Rangeof Motion;” U.S. Pat. No. 5,503,619, entitled “Orthosis for BendingWrists;” U.S. Pat. No. 5,456,268, entitled “Adjustable Orthosis;” U.S.Pat. No. 5,453,075, entitled “Orthosis with Distraction through Range ofMotion;” U.S. Pat. No. 5,395,303, entitled “Orthosis with Distractionthrough Range of Motion;” U.S. Pat. No. 5,365,947, entitled “AdjustableOrthosis;” U.S. Pat. No. 5,285,773, entitled “Orthosis with Distractionthrough Range of Motion;” U.S. Pat. No. 5,213,095, entitled “Orthosiswith Joint Distraction;” and U.S. Pat. No. 5,167,612, entitled“Adjustable Orthosis,” all to Bonutti and herein are expresslyincorporated by reference in their entirety.

SUMMARY OF THE INVENTION

The present invention provides an orthosis for stretching tissue arounda joint of a patient between first and second relatively pivotable bodyportions. The joint and the first and second body portions defining onone side of the joint an inner sector which decreases in angle as thejoint is flexed and defining on the opposite side of the joint an outersector which decreases in angle as the joint is extended.

The orthosis includes a first arm member affixable to the first bodyportion. The first arm member has a first extension member extending atan angle α therefrom. A second arm member affixable to the second bodyportion is also included. The second arm member has a second extensionmember having an arcuate shape extending therefrom. The second and firstextension members are operatively connected, such that the secondextension member travels through the first extension member along anarcuate path when the second arm member is moved from a first positionto a second position relative to the first arm member.

The orthosis further includes a drive assembly for selectively movingthe second extension member relative to the first extension member. Thedrive assembly is mounted onto the first extension member, engaging thesecond extension member. The drive assembly can be manually orautomatically actuated to selectively move the second extension memberrelative to the first extension member.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIG. 1 is a schematic diagram of the orthosis of the present inventionin a flexed position;

FIG. 2 is a schematic diagram of the orthosis of the present inventionin an extended position;

FIG. 3 is a second schematic diagram of the orthosis of the presentinvention in a flexed position;

FIG. 4 shows an adjustable first extension member of the orthosis of thepresent invention;

FIG. 5 shows the adjustable first extension member of FIG. 4 in a secondposition;

FIG. 6 shows a segmented first extension member of the presentinvention;

FIG. 7 shows an arcuate first extension member of the present invention;

FIG. 8 shows an orthosis of the present invention;

FIG. 9 shows an orthosis of the present invention for flexing andextending a wrist joint in a patient;

FIG. 10 shows a non-circular arcuate shaped second extension member ofthe present invention;

FIG. 11 shows an alternative arcuate shaped second extension member ofthe present invention;

FIG. 12 shows a linear shaped second extension member of the presentinvention;

FIGS. 13A and B show exemplary drive assemblies of the presentinvention;

FIG. 14 is a top plan view of portions of an articulating hand padsupport of the present invention;

FIG. 15 is a schematic sectional view of the articulating hand padsupport of FIG. 14;

FIG. 16 depicts a side view of another articulating hand pad support ofthe present invention;

FIG. 17A depicts a top view of the articulating hand pad support of FIG.16;

FIG. 17B depicts a top view of the articulating hand pad support of FIG.16 with the pivoting plate removed;

FIG. 18 shows an orthosis of the present invention;

FIG. 19 shows a hand pad for the orthosis of FIG. 18;

FIG. 20 shows another hand pad for the orthosis of FIG. 18;

FIG. 21 is a schematic diagram of an orthosis of the present invention;

FIG. 22 is a schematic diagram of the orthosis of FIG. 21 in an extendedposition;

FIG. 23 is a schematic diagram of the orthosis of FIG. 21 in a flexedposition;

FIG. 24 is an isometric view of an orthosis of the present invention;

FIG. 25 is a front view of the orthosis of FIG. 24;

FIG. 26 is a side view of the orthosis of FIG. 24;

FIG. 27 is a sectional view of a drive assembly of the orthosis of FIG.24;

FIG. 28 is a section view of an adjustable second cuff for the orthosisof FIG. 24;

FIG. 29 is an expanded view of the drive assembly connection to thefirst member of the orthosis of FIG. 24;

FIG. 30 is a top view of the drive assembly of the orthosis of FIG. 24;

FIG. 31 is an expanded view of another drive assembly connection to thefirst member of the orthosis of FIG. 24;

FIG. 32 depicts a bottom view of the orthosis of FIG. 24.

FIG. 33 depicts a bottom view of a first cuff of the orthosis of FIG.24;

FIG. 34 is a schematic diagram of an embodiment of an orthosis of thepresent invention;

FIG. 35 illustrates another embodiment of the invention utilizing acushion or spring;

FIG. 36 is an embodiment of the invention illustrating the use of a camsurface;

FIG. 37 is an embodiment of the invention utilizing a slideable arcuatesurface;

FIG. 38 illustrates features of an orthosis of the invention where therelative positions of component parts of the orthosis are adjustable;

FIG. 39 is an illustration of the use of gears with an arcuate or camsurface of an orthosis of the invention;

FIG. 40 is a schematic diagram of an embodiment of the invention usingan arcuate path and gear or cam follower;

FIG. 41 illustrates the use of a multi-slotted component to controlmovement of the orthosis; and

FIG. 42 illustrates an embodiment of the invention where linear movementof a component is translated into rotational and translational movementof another component of the orthosis.

DETAILED DESCRIPTION OF THE INVENTION

The present invention relates to an orthosis for moving a joint betweenfirst and second relatively pivotable body portions. The joint and thefirst and second body portions define on one side (the flexor side) ofthe joint an inner sector which decreases in angle as the joint isflexed (bent) and on the opposite side (the extensor side) of the jointan outer sector which decreases in angle as the joint is extended(straightened). The orthosis of the present invention is affixable toeither the flexor or extensor side of the joint for treatment of flexionor extension contractures.

Referring now to the drawing figures in which like reference designatorsrefer to like elements, there is shown in FIG. 1, a schematic of theorthosis 10 of the present invention. The orthosis 10 includes a firstarm member 12 attachable to the first body portion and a second armmember 14 attachable to the second body portion, wherein a joint axis ofrotation 16 is interposed between and offset from the first and secondarm members 12 and 14. The first and second arm members 12 and 14 areoperatively connected to each other offset from the joint axis 16.

The first arm member 12 of the orthosis 10 includes a first extensionmember 18, which extends at angle α from the first arm member 12. Thesecond arm member 14 of the orthosis 10 includes a second extensionmember 20 extending therefrom and having an arcuate shape. The first andsecond extension members 18 and 20 are operatively connected at point“P,” such that in operation the second extension member 20 travels alongan arcuate path about and substantially through point “P.” The arcuateshape of the second extension member 20 results in the second bodyportion rotating about the joint axis 16, when the second arm member 14is moved from a first position to a second position relative to thefirst arm member 12. The angle α between the first extension member 18and the first arm member 12 and the radius of curvature of the secondextension member 20 are a function of the joint to be treated and thedegree of flexion or extension contractures.

The orthosis further includes a drive assembly 22 at point “P.” Thedrive assembly connects the first and second extension members 18 and 20for applying force to the first and second arm members 12 and 14 topivot the first and second body portions relative to each other aboutthe joint.

The orthosis 10 of the present invention is shown having an angle α suchthat the operative connection, at point “P,” of the first and secondextensions 18 and 20 is located in a plane “A” passing through the jointaxis 16, wherein plane “A” is substantially orthogonal to a longitudinalaxis of the first arm member 12. This position of point “P” provides anangle β₁ between the second arm member 14 and the joint axis 16, whereinβ₁ is the maximum angle of flexion. As shown in FIG. 2, the secondextension member includes a stop 24. The stop 24 acts to limit the angleof maximum extension γ between the second arm member 14 and the jointaxis 16. An increase in the length of the stop 24 will decrease theangle of maximum extension γ. A decrease in the length of the stop 24will increase the angle of maximum extension γ.

Referring to FIG. 3, the maximum flexion angle can be increased byincreasing the angle α. An increase in the angle α will move the point“P” to a location “in front of” the plane “A.” This position of point“P” provides an angle β₂ between the second arm member 14 and the jointaxis 16 in maximum flexion, wherein β₂ is greater than β₁. The greaterthe angle α, the greater the angle of maximum flexion.

Alternatively, (not shown) a decrease in the angle α will move the point“P” to a location “behind” the plane “A.” This position of point “P”provides an angle β₃ between the second arm member 14 and the joint axis16 in maximum flexion, wherein β₃ is less than β₁. The smaller the angleα, the smaller the angle β of maximum flexion.

Referring to FIG. 4, the first extension member 18 is selectively,pivotally connected at location 26 to the first arm member 12. Thepivotal connection 26 of the first extension member 18 permits the angleα between the first extension member 18 and the first arm member 12 tobe selectively increased and decreased, increasing and decreasing therange of motion. In a first position 28, the first extension member 18is positioned at an angle α₁, wherein the operative connection, at point“P,” of the first and second extension members 18 and 20 is located in aplane “A” passing through the joint axis 16, wherein plane “A” issubstantially orthogonal to a longitudinal axis of the first arm member12. The first position 28 of point “P” provides a maximum angle offlexion of β₁. The second extension member stop 24 acts to limit theangle of maximum extension γ₁ between the second arm member 14 and thejoint axis 16.

Referring to FIG. 5, in a second position 30 the angle α is increased toan angle α_(z), positioning the point “P” to a location “in front of”the plane “A.” The second position 30 of point. “P” provides a maximumangle of flexion of β₂, wherein β₂ is greater than β₁. The secondextension member stop 24 acts to limit the angle of maximum extension γ₂between the second arm member 14 and the joint axis, wherein γ₂ is lessthe γ₁.

The selective pivotal connection 26 of the first extension member 18 tothe first arm member 12 can have a plurality of selectable positions.The angle α between the first arm member 12 and the first extension 18can be selectively increased to move the point “P”, on, “in front of” or“behind” the plane “A.” It is also envisioned that a positioned can beselected to increase the angle α between the first arm member 12 and thefirst extension 18 sufficiently to move the point “P” “in front of”plane “A” and “above” the longitudinal axis of the first arm member 12,maximizing the maximum angle of flexion β.

The orthosis 10 of the present invention can be connected to the flexorside of the first and second body portions of the joint, which resultsin a decrease in angle as the joint is flexed (bent) and an increase inangle and the joint is extended (straightened). Alternatively, orthosis10 of the present invention can be connected to the extensor side of thejoint, which results in a decrease in angle as the joint is extendedstraightened and an increase in angle as the joint is flexed (bent).

The previous description of the first arm member 12 depicts a firstextension 18 having a substantially linear shape, extending at an angleα from the first arm member 12. However, it is within the scope of thepresent invention that the first extension member 18 can be any shapeextending from the first arm member 12 which positions the point “P” inthe desired relationship to the plane “A.” Referring to FIG. 6, asegmented first extension member is shown, including a first extensionmember segment 18 a and a second extension member segment 18 b. Thefirst and second extension member segments 18 a and 18 b extend from thefirst arm member 12, positioning the point “P” at an angle α from thefirst arm member 12. Referring to FIG. 7, an arcuate first extensionmember 18 c is shown. The arcuate extension member 18 c extends from thefirst arm member 12, positioning the point “P” at an angle α from thefirst arm member 12.

Referring to FIG. 8, the orthosis 10 of the present invention includes afirst arm member 12 attachable to the first body portion and a secondarm member 14 attachable to the second body portion, wherein the jointaxis 16 is interposed between and offset from the first and second armmembers 12 and 14. The first and second arm members 12 and 14 areconnected with each other offset from the joint axis 16.

The first arm member 12 of the orthosis 10 includes a first extensionmember 18, which extends at angle α from the first arm member 12. Thesecond arm member 14 of the orthosis 10 includes a second extensionmember 20, having an arcuate shape. The first and second extensionmembers 18 and 20 are operatively connected a point “P,” such that inoperation the second extension member 20 travels along an arcuate pathabout and substantially through point “P.” The arcuate shape of thesecond extension member 20 results in the second body portion rotatingabout the joint axis 16, when the second arm member 14 is moved from afirst position to a second position relative to the first arm member 12.The angle α between the first extension member 18 and the first armmember 12 and the radius of curvature of the second extension member 20are a function of the joint to be treated and the degree of flexion orextension contractures.

A first cuff 32 is attached to the first arm member 12, wherein thefirst cuff 32 is positionable about the first body portion. The firstcuff 32 is attached to the first body portion by cuff straps. The firstcuff 32 secures the first body portion to the first arm member 12. Asecond cuff 34 is attached to the second an member 14, wherein thesecond cuff 34 is positionable about the second body portion. The secondcuff 34 is attached to the second body portion by cuff straps. Thesecond cuff 34 secures the second body portion to the second arm member14. (The term “cuff” as used herein means any suitable structure fortransmitting the force of the orthosis 10 to the limb portion itengages.)

In an exemplary use, the orthosis 10 is operated to extend a joint inthe following manner. The first cuff 32 is fastened about the first bodyportion tightly enough that the first arm member 12 may apply torque tothe first body portion without having the first cuff 32 slide along thefirst body portion. Similarly, the second cuff 34 is fastened securelyaround the second body portion so that the second arm member 14 mayapply torque to the second body portion without the second cuff 34sliding along the second body portion. The orthosis 10 is attached tothe first and second body portions in a first position. The second armmember 14 is rotated from the first position to a second position,relative to the first arm member 12, rotating the second body portionabout the joint axis 16 stretching the joint. As the second arm member14 is rotated to the second position, the second extension member 20travels along an arcuate path about and substantially through point “P.”The orthosis 10 is maintained in the second position for a predeterminedtreatment time providing a constant stretch to the joint. After theexpiration of the treatment time, the second arm member 14 is moved backto the first position, relieving the joint. Optionally, the second armmember 14 can be rotated to a third position, increasing the stretch onthe joint. The second arm member 14 can be rotated at discrete timeintervals to incrementally increase the stretch of the joint through thetreatment cycle. After completion of the treatment cycle, the second armmember is returned to the first position for removal of the orthosis 10.

The first and second arm members 12 and 14 are rigid members made of,for example, aluminum, stainless steel, polymeric, or compositematerials. The arms are rigid so as to be able to transmit the necessaryforces. It should be understood that any material of sufficient rigiditycan be used.

In an embodiment, the components of the orthosis 10 of the presentinvention are made by injection molding. Generally for injectionmolding, tool and die metal molds of the orthosis 10 components areprepared. Hot, melted plastic material is injected into the molds. Theplastic is allowed to cool, forming components. The components areremoved from the molds and assembled. The cuff portions 32 or 34 can beindividual molded and attached to the arm members 12 or 14.Alternatively, the cuff portions can be molded as an integrated part ofthe arm members 12 or 14.

In use, the orthosis 10 can be connected to the flexor side of the firstand second body portions of the joint, which results in a decrease inangle as the joint is flexed (bent) and an increase in angle as thejoint is extended (straightened). Alternatively, orthosis 10 of thepresent invention can be connected to the extensor side of the joint,which results in a decrease in angle as the joint is extendedstraightened and an increase in angle as the joint is flexed (bent).

In an embodiment, the orthosis 10 includes a first cuff 32 forattachment to a first body portion, and a second cuff 34 for attachmentto a second body portion. The first body portion is joined to the secondbody portion at a joint, around which is located, as is well known, softtissue. Each of the first and second cuffs 32 and 34 includes loopconnectors for receiving straps extending around the body portions toclamp the cuffs 32 and 34 to the body portions.

The first cuff 32 is mounted for sliding movement on the first armmember 12 and is slidable along the first arm member 12 in a manner asdescribed below. The second cuff 34 is mounted for sliding movement on asecond arm member 14 and is slidable along the second arm member 12 in amanner as described below.

Bending a Joint in Extension:

In operation of the orthosis 10 to extend the joint, the orthosis 10starts at a more flexed position. The first and second cuffs 32 and 34are clamped onto the first and second body portions, respectively, bystraps, tightly enough so that the cuffs 32 and 34 can apply torque tothe body portions to extend the joint. The second arm member 14 isrotated from the first position to a second position, relative to thefirst arm member 12, rotating the second body portion about the jointaxis 16 stretching the joint. As the second arm member 14 is rotated tothe second position the second extension member 20 travels along anarcuate path about and substantially through point “P.” The orthosis 10is maintained in the second position for a predetermined treatment timeproviding a constant stretch to the joint.

As the orthosis 10 is rotated from the first position to the secondposition, extending the joint, the first and second cuffs 32 and 34 movealong the first and second arm members 12 and 14. The first cuff 32moves inwardly along the first arm member 12. Similarly, the second cuff34 moves inwardly along the second arm member 14. Because the cuffs 32and 34 are clamped onto the first and second body portions as describedabove, the outward pivoting movement of the first and second arm members12 and 14 and the cuffs 32 and 34 causes the joint to be extended asdesired. However, this extension of the joint can place strongdistractive forces on the soft tissues around the joint. The slidingmovement of the cuffs 32 and 34, inwardly along the first and second armmembers 12 and 14, helps to limit these distractive forces bycounteracting the outward movement of the first and second arm members12 and 14. The cuffs 32 and 34 slide inwardly along the first and secondarm members 12 and 14 a distance far enough so that the joint is onlyslightly distracted during extension. Thus, the detrimental effects ofstrong distractive forces normally generated in forced extension of ajoint are avoided, being replaced with the beneficial effects of limitedand controlled distraction.

Bending a Joint Flexion:

In operation of the orthosis 10 to flex the joint, the orthosis 10starts at a more extended position. The first and second cuffs 32 and 34are clamped onto the first and second body portions, respectively, bystraps, tightly enough so that the cuffs 32 and 34 can apply torque tothe body portions to extend the joint. The second arm member 14 isrotated from the first position to a second position, relative to thefirst arm member 12, rotating the second body portion about the jointaxis 16 stretching the joint. As the second arm member 14 is rotated tothe second position the second extension member 20 travels about andsubstantially though point “P,” along an arcuate path. The orthosis 10is maintained in the second position for a predetermined treatment timeproviding a constant stretch to the joint.

As the orthosis 10 is rotated from the first position to the secondposition, flexing the joint, the first and second cuffs 32 and 34 movealong the first and second arm members 12 and 14. The first cuff 32moves outwardly along the first arm member 12. Similarly, the secondcuff 34 moves outwardly along the second arm member 14. Because thecuffs 32 and 34 are clamped onto the first and second body portions theinward pivoting movement of the first and second arm members 12 and 14and the cuffs 32 and 34 causes the joint to be flexed as desired.However, this flexion of the joint can place strong compressive forceson the soft tissues around the joint. The sliding movement of the cuffs32 and 34, outwardly along the first and second arm members 12 and 14,helps to limit these compressive forces by counteracting the inwardmovement of the first and second arm members 12 and 14. The cuffs 32 and34 slide outwardly along the first and second arm members 12 and 14 adistance far enough so that the joint is only slightly compressed duringflexion. Thus, the detrimental effects of strong compressive forcesnormally generated in forced flexion of a joint are avoided, beingreplaced with the beneficial effects of limited and controlledcompression.

Referring now to FIG. 9, the orthosis 10 can be used to bend a wrist inflexion or extension. The orthosis 10 includes a first arm member 12attachable to the forearm of a patient. The first cuff 32 is clampedonto the forearm by straps. A second arm member 14, operativelyconnected to the first arm member 12, is attachable to the hand of thepatient, wherein the axis of the wrist joint is interposed between andoffset from the first and second arm members 12 and 14. The second armmember 14 includes a base member 36 attach thereto. A hand pad 38 isattached to the base member 36. The hand pad 38 is clamped onto the handby straps, tightly enough so that the second arm member 14 can applytorque to the joint. The hand pad 38 can be shaped to conform to thepalm or the back surface of the hand.

Bending Wrist in Flexion:

When a wrist is to be bent in flexion, the first cuff 32 is connectedwith the forearm and the hand pad 38 is connected with the palm of thehand. The first cuff 32 and hand pad 38 are clamped onto the forearm andhand, respectively, by straps, tightly enough so that they can applytorque to flex the joint. The second arm member 14 is rotated from thefirst position to a second position, relative to the first arm member12, rotating the hand about the wrist joint axis 16 stretching thejoint. As the second arm member 14 is rotated to the second position thesecond extension member 20 travels along an arcuate path about andsubstantially through point “P.” The orthosis 10 is maintained in thesecond position for a predetermined treatment time providing a constantstretch to the wrist joint.

Bending Wrist in Extension:

When a wrist is to be bent in extension, the first cuff 32 is connectedwith the forearm and the hand pad 38 is connected with the back surfaceof the hand. The first cuff 32 and hand, pad 38 are clamped onto theforearm and back surface of the hand, respectively, by straps, tightlyenough so that they can apply torque to flex the joint. The second armmember 14 is rotated from the first position to a second position,relative to the first arm member 12, rotating the hand about the wristjoint axis 16 stretching the joint. As the second arm member 14 isrotated to the second position the second extension member 20 travelsalong an arcuate path about and substantially through point “P.” Theorthosis 10 is maintained in the second position for a predeterminedtreatment time providing a constant stretch to the wrist joint.

In an embodiment, the hand pad 38 is removable attached to the basemember 36. The hand pad 38 includes a first surface, which has asubstantially convex shape, to conform to the palm of the hand. A secondsurface, opposite the first surface, is also included, having asubstantially concave shape, to conform to the back surface of the hand.The hand pad 38 can be removable attached to the base member 36 suchthat the first or second surfaces engages the hand of the patient.

For example, the hand pad 38 is removably secured to base member 36 bydetent pin 40. The removable securing of the hand pad 38 allows theorthosis 10 to be used for both flexion and extension of the wrist. Inflexion, the hand pad 38 is connected to the base member 36 with thefirst surface facing “up” to conform to the palm of the hand. Inextension, the hand pad 38 is connected to the base member 36 with thesecond surface facing “up” to conform to the back surface of the hand.

The base member 38 can be mounted for sliding movement on the second armmember 14 and is slidable along the second arm member 14 in a manner asdescribed below.

Bending Wrist in Extension:

In operation of the orthosis 10 to extend the wrist joint, the orthosis10 starts at a more flexed position. The first cuff 32 is connected withthe forearm and the hand pad 38 is connected with the palm of the hand.The first cuff 32 and hand pad 38 are clamped onto the forearm and palmof the hand so as to apply torque to extend the wrist joint. The secondarm member 14 is rotated from the first position to a second position,relative to the first arm member 12, rotating the hand about the wristjoint axis 16 stretching the wrist joint. As the second arm member 14 isrotated to the second position the second extension member 20 travelsalong an arcuate path about and substantially through point “P.” Theorthosis 10 is maintained in the second position for a predeterminedtreatment time providing a constant stretch to the joint.

As the orthosis 10 is rotated from the first position to the secondposition, extending the joint, the base member 36 and hand pad 38 movealong the second arm member 14. The base member 36 and hand pad 38 moveinwardly along the second arm member 14. Because the cuff 32 and handpad 38 are clamped onto the forearm and hand the outward pivotingmovement of the first and second arm members 12 and 14 causes the jointto be extended as desired. However, this extension of the joint canplace strong distractive forces on the soft tissues around the joint.The sliding movement of the base member 36 and hand pad 38, inwardlyalong the second arm member 14, helps to limit these distractive forcesby counteracting the outward movement of the second arm members 12 and14. The base member 36 and hand pad 38 slide inwardly along the secondarm member 14 a distance far enough so that the joint is only slightlydistracted during extension. Thus, the detrimental effects of strongdistractive forces normally generated in forced extension of a joint areavoided, being replaced with the beneficial effects of limited andcontrolled distraction.

Bending Wrist in Flexion:

In operation of the orthosis 10 to flex the wrist joint, the orthosis 10starts at a more extended position. The first cuff 32 is connected withthe forearm and the hand pad 38 is connected with the back surface ofthe hand. The first cuff 32 and hand pad 38 are clamped onto the forearmand back surface of the hand so as to apply torque to flex the wristjoint. The second arm member 14 is rotated from the first position to asecond position, relative to the first arm member 12, rotating the handabout the wrist joint axis 16 stretching the wrist joint. As the secondarm member 14 is rotated to the second position the second extensionmember 20 travels along an arcuate path about and substantially throughpoint “P.” The orthosis 10 is maintained in the second position for apredefined treatment time providing a constant stretch to the joint.

As the orthosis 10 is rotated from the first position to the secondposition, flexing the joint, the base member 36 and hand pad 38 movealong the second arm member 14. The base member 36 and hand pad 38 moveoutwardly along the second arm member 14. Because the cuff 32 and handpad 38 are clamped onto the forearm and hand the inward pivotingmovement of the first and second arm members 12 and 14 causes the jointto be flexed as desired. However, this flexing of the joint can placestrong compressive forces on the soft tissues around the joint. Thesliding movement of the base member 36 and hand pad 38, outwardly alongthe second arm member 14, helps to limit these compressive forces bycounteracting the inward movement of the first and second arm members 12and 14. The base member 36 and hand pad 38 slide outwardly along thesecond arm member 14 a distance far enough so that the joint is onlyslightly compressed during extension. Thus, the detrimental effects ofstrong compressive forces normally generated in forced flexion of ajoint are avoided, being replaced with the beneficial effects of limitedand controlled compression.

In the above description, the hand pad 38 is shown sliding inwardly andoutwardly along the second arm member 14. However, it is contemplatedthat the hand pad 38 can slide in other directions. For example, thehand pad 38 can slide substantially orthogonal to the second arm member14, wherein the substantially orthogonal directions can have an arcuatepath. Similarly, as discussed in more detail below, it is contemplatedwithin the scope of the present invention that hand pad 38 can beconnected to the second arm member 14 such that hand pad 38 can exhibitboth longitudinal and orthogonal motion (and combinations thereof) withrespect to the second arm member 14.

In the above description, the second extension member 20 is shown anddescribed as having a substantially circular arcuate shape, positioningthe axis of rotation at the joint axis 16. However, it is contemplatedthat the second extension member 20 can have alternative shapes.

Referring to FIG. 10, the second arm member 14 is shown having anon-circular arcuate shaped second extension member 44. The non-circulararcuate shaped second extension member 44 provide an axis of rotationwhich changes as the second arm member 14 is moved from the firstposition to the second portion. As such, as the second arm member 14 ismoved from the first position to the second portion the second bodyportion will exhibit both a rotational motion, about the joint axis 16,and a translational motion, distracting or compressing the joint.

In the previously described embodiments, the arcuate shape of the secondextension member 20 or 44 as shown have concave radius of curvaturerelative to the joint 16. However, referring to FIG. 11, it iscontemplated that the second extension member 18 or 44 can have a convexradius of curvature relative to the joint 16. Similar to the concaveradius of curvature, the convex arcuate shape of the second extensionmember 18 or 44 results in the second body portion rotating about thejoint axis 16, when the second arm member 14 is moved from a firstposition to a second position relative to the first arm member 12.

Referring to FIG. 12, the second arm member 14 of the orthosis 10includes a second extension member 48 extending therefrom and having alinear shape. The first and second extension members 18 and 48 areoperatively connected at point “P.” such that in operation the secondextension member 48 travels along a linear path through point “P.” Thelinear shape of the second extension member 48 results in the secondbody portion being translated with respect to the first body portion.The translational movement of the second arm member 14 results is adistraction or compression of the joint when the second arm member 14 ismoved from a first position to a second position relative to the firstarm member 12.

As discussed further below, the hand pad can be mounted fortranslational and rotational movement on the base member.

Drive Assembly:

Referring to FIGS. 9 and 13A, the drive assembly 22 of the orthosisincludes a gear system. As previously noted, the components of theorthosis, including the drive assembly 22, can be made by injectionmolding a polymer. The drive assembly 22 is supported in the firstextension member 18, including a gear 50 rotatable about point “P.” Ashaft 52, attached to the gear 50, extends from first extension member18. A knob 54 is connected to the shaft 52, opposite the gear 50, formanually rotating the gear 50. The second extension member 20 includes aseries of teeth 56 along an inner surface 58. The second extensionmember 20 is threaded through the first extension member 18, such thatthe teeth 56 on the second extension member 20 engage the gear 50. Therotation of the knob 56 causes the gear 50 to rotate, pushing or pullingthe second extension member 20 through the first extension member 18.The drive assembly 22 includes a locking or breaking mechanism whichprevents the gear 50 from rotating absent am applied force rotation ofthe knob 46. Such a lock or breaking mechanism can include a compressionwasher or other known gear locking or breaking mechanisms.

In another embodiment, as shown in FIG. 13B, the shaft 52 is attached tothe gear 50 and extends from first extension member 18. The knob 54 isconnected to the shaft 52 opposite the gear 50 for manually rotating thegear 50. The second extension member 20 includes a series of teeth 56along an inner surface 58. The teeth 56 can extend fully or partiallyalong the width of the inner surface 58. A secondary gear 51 ispositioned between the gear 50 and the inner surface 58, where thesecondary gear 51 engages gear 50. The second extension member 20 isthreaded through the first extension member 18, such that the teeth 56on the second extension member 20 engage the secondary gear 51. Therotation of the knob 56 causes the gear 50 to rotate, thereby rotatingthe secondary gear 51 and pushing or pulling the second extension member20 through the first extension member 18. The ratio between gear 50 andsecondary gear 51 is selected to permit an easy rotation of the knob 54,moving of the second extension member 20 through the first extensionmember 18. The drive assembly 22 includes a locking or breakingmechanism which prevents the gear 50 from rotating absent am appliedforce rotation of the knob 46. Such a lock or breaking mechanism caninclude a compression washer or other known gear locking or breakingmechanisms.

The drive assembly 22 is described as utilizing a gear system. However,it is contemplated that other known drive systems can be used to movethe second extension member 20 through the first extension member 18,for example a friction type drive system. Regardless of the drive systemused, the joint orthosis of the present invention can act as a brace,restricting the relative movement of the first and second body portionsto one degree of freedom (e.g. flexion and extension about the joint).Thus, drive assembly 22 can be configured to allow free motion in onedegree of freedom. This can be achieved in a number of different ways.For example, gear 50 can be positioned such that it does not engageteeth 56.

In an alternative embodiment, the drive assembly 22 for an orthosis 10in accordance with the present invention can be actuated by a motorinstead of by a manually actuatable member, such as the knob 54.

In an embodiment, an electric motor is mounted to the shaft 52 forrotation of the gear 50. A battery provides electric power to the motor.Alternatively, the motor can be supplied with external power. Amicroprocessor controls the operation of the motor. The microprocessorand motor together can be used to cycle the first and second arm members12 and 14 through extension and flexion; to move the first and secondarm members 12 and 14 in one pivotal direction a certain amount, holdthere while tissue stretches, then move further in that direction; or inany other manner. In another manner of use, the orthosis can be set tocycle to one end of the joint's range of motion and hold there for apredetermined period of time, then cycle to the other end of the joint'srange of motion and hold there. The programming and control of themicroprocessor is within the skill of the art as it relates to drivingthe motor to control the first and second arm members 12 and 14 to movein known manners. This embodiment is ideally suited for continuouspassive motion exercise, because the orthosis is portable and becausethe motor can be programmed with the desired sequence of movements.

It should be understood that the particular physical arrangement of themotor, the battery, and the microprocessor is not the only possiblearrangement of those elements. The invention contemplates that otherarrangements of these or similarly functional elements are quitesuitable, and thus, the invention is intended to cover any sucharrangement. Additionally, another type of power source, other than anelectric motor, can also be used. For example, the use of a hydraulic orpneumatic motor as the drive mechanism is contemplated.

Referring to FIGS. 14 and 15, another embodiment in which the hand pad38 articulates with respect to the second arm member 14 is shown. Thesecond arm member 14 has a circular base member 40 attached thereto. Thecircular base member 40 supports a circular base plate 42. A circularcover 44 extends upwardly from the circular base member 40 and has aportion 46 extending radially inwardly toward a vertical axis 48 todefine a slide chamber 50.

A hand pad support slider 52 is received in the slide chamber 50. Thesupport slider 52 has an upper portion 54 to which the hand pad 38 isattached. The upper portion 54 is connected by a neck 56 to a circularplanar portion 58. Two annular bearing races 60 extend downwardly fromthe planar portion 58 and secure between them a plurality of ballbearings 62. A washer 64 is disposed above the bearings 62. The ballbearings 62 support the slider 52 and thus the hand pad 38 for slidingmovement in any direction within the slide chamber 50. The hand pad 38can be made self-centering by springs 66.

Thus, the hand pad 38 is slidable relative to the circular base member40 in any direction for a limited extent. As indicated by the arrow 68,the hand pad 38 is slidable fore and aft within the extent of travelallowed by the support slider 52 within the slide chamber 50. Asindicated by the arrow 70, the hand pad 38 is slidable laterally withinthe extent of travel allowed by the support slider 52 within the slidechamber 50. With these two combined, it can be seen that the rollerbearing assembly provides a compound of movement of the hand pad 38.

Referring to FIGS. 16, 17A and 178, another embodiment 80 in which thehand pad 38 articulates with respect to the second arm member 14 isshown. The second arm member 14 has a sliding base member 82 slidinglymounted thereto in similar fashion to base member 36. The sliding basemember 82 supports a fixed base plate 84 attached thereto. A pivotalbase plate 86 is pivotally connected to the fixed base plate 84, wherethe pivotal base 86 plate can arcuately pivot with respect to the fixedbase plate 84 and the second arm member 14.

The pivotal base plate 86 is pivotally secured to the fixed base plate84 by threaded members 88 and 90 extending through an arcuate slot 92 inthe pivotal base plate 86. The threaded members 88 and 90 are threadedin threaded holes 94 and 96 in the fixed plate 84. In this manner thepivotal base plate 86 can travel along the arcuate slot 92 with respectto the fixed base plate 84. The hand pad (not shown) can be removableattached to the pivotal base plate 86.

In instances where a joint is misaligned, fixing the position of thejoint can result in unwanted torsional forces being applied to thejoint. The articulation of the hand pad permits the joint to self-align,such that the joint can be rotated about its axis without theapplication of torsional forces on the joint.

Referring now to FIG. 18, an orthosis 100 can be used to bend a wrist inflexion or extension. The orthosis 100 includes a first arm member 102attachable to the forearm of a patient. The first cuff 104 is clampedonto the forearm by straps 106. A second arm member 108, operativelyconnected to the first arm member 102, is attachable to the hand of thepatient, wherein the axis of the wrist joint is interposed between andoffset from the first and second arm members 102 and 108. The second armmember 108 includes articulating member 80 attached thereto. A hand padcan be attached to the pivotal base plate 86. The hand is clamped ontothe hand pad by top member 110 and strap 112, tightly enough so that thesecond arm member 108 can apply torque to the joint. The hand pad can beshaped to conform to the palm or the back surface of the hand.

Referring to FIG. 19, a hand pad 114 is provided, where the hand pad 114can be removably attached to the pivotal base plate 86. For example, ahook and loop tape 116 can be provided on the hand pad 114 and thepivotal base plate 86. The hand pad 114 is shaped to conform to the palmof the hand.

Referring to FIG. 20, another hand pad 118 is provided, where the handpad 118 can be removably attached to the pivotal base plate 86.Similarly, the hook and loop tape 116 can be provided on the hand pad118 and the pivotal base plate 86. The hand pad 118 is shaped to conformto a top surface of the hand.

Another embodiment of an orthosis of the present invention is intreatment of a toe of a patient's foot. While this embodiment isbelieved to provide significant improvements in this area of treatment,it may likewise be of benefit in treating other joints, such as ankles,knees, hips, fingers, wrists, elbows, shoulders, or the spine.

Furthermore, while many examples provided herein may illustrate theinvention used to treat the metatarsal and proximal phalanx of the toe,these examples are non-limiting on other joints of the toe that also maybe treated by the present invention. It is understood by those skilledin the art that the other joints of the toe may be flexed or extended,without departing from the spirit and scope of the invention.Additionally, the present invention is described in use on the “big” toeor hallux on the foot. Thus, it should be understood by those skilled inthe art that the present invention is equally applicable for use on thesecond, third, fourth and minimus toes of the foot.

Each toe in the foot extends from the metatarsal bone and is formed bythe proximal phalanx, middle phalanx, and distal phalanx, each of whichis respectively pivotally connected to form a joint there between. Theorthosis of the present invention may be configured to flex or extend(or both) a toe joint, where the joint defines an inner sector on theflexor side that decreases in angle as the joint is flexed (bent) and anouter sector on the extensor side that decreases in angle as the jointis extended (straightened).

Referring now to the figures in which like reference designators referto like elements, there is shown in FIG. 21, a schematic of the orthosis200 of the present invention. The orthosis 200 includes a first member202 attachable to a first body portion, such as a user's foot. The shapeand configuration of the first member 202 may be selected to support orconform generally to a patient's foot. For example, the first member 202may be a platform that contacts or supports the underside of a user'sfoot. Sidewalls or curved edges may be provided to help position,cradle, or securely hold the foot in proper position.

Alternatively, the first member 202 may have a profile or shape thatgenerally conforms to a user's arch, shoe size, or foot width so that itfits more comfortably, holds the foot securely in place, or improvesalignment of the device so that the range of motion imparted by thedevice corresponds to a joint's healthy range of motion. This conformingshape or profile may be accomplished, for instance, by providinginterchangeable platforms corresponding to different foot sizes andshapes. The interchangeable platform may be selectively removed andreplaced by an interchangeable platform of a different size.Alternatively, the first member 202 may have adjustable surfaces thatcan be resized or repositioned to better support or correspond to apatient's foot. For example, the overall length of the first member 202may be adjustable, or the width of the first member 202 near the toesmay be adjusted to account for different foot widths. In addition,raised walls or edges that support the feet may be selectively moveableso that they can be moved to accommodate different foot sizes. Once thefoot is in place and the edges are moved to their desired position, theymay be selectively locked or secured in place to help hold the foot inplace. Additionally, the first member 202 may be configured with anarch, which in some instances also may be adjustable such as by havinginterchangeable arch inserts, by configuring the arch to be inflatable,or the like.

The first member 202 is operatively associated with or connected to asecond member 204 so that the first and second members 202 and 204 maymove or rotate with respect to each other. As shown in FIG. 21, thesupporting surface of the first member 202 may be offset from thesupporting surface of the second member 204. This amount of offsetprovided may vary from patient to patient or from joint to joint, and insome cases an offset may not be provided. Thus, it may be advantageousto allow the offset of the orthosis 200 to be adjustable so that aphysician or user may change its size as needed to improve comfort, fit,or operation of the orthosis 200.

In use, the second member 204 may be attachable to a second bodyportion, such as at least one toe on the foot so that the relativemovement of the two members also causes movement of the joint. As shownin FIG. 22, the orthosis 200 may have an axis of rotation 206 that isaligned with the axis of rotation of the joint. In this manner, theinstantaneous axis of rotation (IAR) of the first and second members 202and 204 may better match the IAR of the treated joint. As will bediscussed in greater detail below, while the axis of rotation 206 of thedevice is illustrated in FIGS. 21-23 as occurring only along a singleline, the axis of rotation 206 may also shift or move depending on therelative positioning of the first and second members 202 and 204 in amanner that corresponds to changing axis of rotation that a joint mayexperience through its range of motion. The first and second members 202and 204 are operatively connected to each other, offset from theorthosis axis 206.

The first member 202 of the orthosis 200 includes a first extensionmember 208 extending therefrom. The second member 204 of the orthosis200 includes a second extension member 210 extending therefrom andhaving an arcuate shape. The first and second extension members 208 and210 are operatively connected at point “P,” such that in operation thesecond extension member 210 travels along an arcuate path about andsubstantially through point “P.” The arcuate shape of the secondextension member 210 results in the toe rotating about the orthosis axis206, or alternatively about a moving IAR, when the second member 204 ismoved from a first position to a second position relative to the firstmember 202.

The first extension member 208 can extend substantially vertically fromthe first member 12 or extend at an angle α from the first member 202.In one embodiment of the invention, the angle α and the radius ofcurvature of the second extension member 210 are configured such that ofthe orthosis axis 206 is aligned with the axis of rotation of the joint.The previous description of the first member 202 depicts a firstextension 208 having a substantially linear shape, extending at an angleα from the first member 202. However, it is within the scope of thepresent invention that the first extension member 208 can be any shapeextending from the first member 202 which aligns orthosis axis 206 withthe axis of rotation of the joint. Furthermore, as mentioned previouslyand again below, in some instances the axis of rotation of the joint maychange or move slightly. Therefore, in some instances it may bedesirable for the orthosis to mimic the IAR of the joint. As will beillustrated in detail below, this can be accomplished in several ways.One modification of the embodiment of the invention shown in FIG. 21,for instance, may be for the second extension member 210 not to have aconstant radius of curvature.

The orthosis 200 further includes a drive assembly 212, which isillustrated in FIG. 21 at or near point “P.” In this embodiment, thedrive assembly 212 is operably connected to the first and secondextension members 208 and 210 for applying force to the first and secondmembers 202 and 204 to pivot the second body portion about the orthosisaxis 206. As will be shown below in additional embodiments, the driveassembly 212 may be configured or disposed to interact with or operateon one of the first or second members 202 and 204 independently.

Referring to FIG. 22, in order for the orthosis 200 to extend the jointthe first and second members 202 and 204 may be affixed to the first andsecond body portions, respectively, tightly enough so that the first andsecond members 202 and 204 can apply torque to extend the joint.

The second extension member 210 is moved through the drive assembly 212from a first position to a second position, relative to the firstextension member 208, rotating the second member 204 and the second bodyportion about the orthosis axis 206 stretching the joint. As the secondmember 204 is rotated to the second position, the second extensionmember 210 travels at least partially through point “P” and may travelsubstantially through this point for a large range of motion. Becausethe first and second members 202 and 204 are affixed to the first andsecond body portions, the outward pivoting movement of the second member204 causes the joint to be extended as desired. The orthosis 200 maythen be maintained in the second position for a predetermined treatmenttime providing a constant stretch to the joint. The orthosis mayalternatively be configured to impart a constant force or load on thejoint or may utilize the techniques of Static Progressive Stretch asdescribed in co-pending application Ser. No. 11/203,516, entitled “Rangeof Motion System and Method”, and filed on Aug. 12, 2005, the entiretyof which is incorporated by reference.

Returning to the example where the orthosis is maintained in the secondposition, after the expiration of the treatment time, the second member204 may then be moved back to the first position, relieving the joint.Optionally, the second member 204 can be rotated to a third position,increasing the stretch on the joint, or partially reducing it to allowlimited relaxation of the surrounding tissue. The second member 204 canbe rotated at discrete time intervals to incrementally increase, reduce,or vary the stretch of the joint through the treatment cycle. Aftercompletion of the treatment cycle, the second arm 204 is returned to thefirst position for removal of the orthosis 200.

Referring to FIG. 23, in operation of the orthosis 200 to flex thejoint. The first and second members 202 and 204 are affixed to the firstand second body portions, respectively, tightly enough so that the firstand second members 202 and 204 can apply torque to extend the joint. Acuff strap, laces, or other retaining device may be used to securelyassociate respective body portions of the joint with the first andsecond members 202, 204. The second extension member 210 is movedthrough the drive assembly 212 from the first position to a secondposition, relative to the first extension member 208, rotating thesecond member 204 and the second body portion about the orthosis axis206 stretching the joint. As the second member 204 is rotated to thesecond position, the second extension member 210 travels substantiallythrough point “P.” Because the first and second members 202 and 204 areaffixed to the first and second body portions, the inward pivotingmovement of the second member 204 causes the joint to be flexed asdesired. The orthosis 200 is maintained in the second position for apredetermined treatment time providing a constant stretch to the joint.

After the expiration of the treatment time, the second member 204 ismoved back to the first position, relieving the joint. Optionally, thesecond member 204 can be rotated to a third position, therebyincreasing, decreasing, or otherwise varying the stretch on the joint.The second member 204 can be rotated at discrete time intervals toincrementally increase the stretch of the joint through the treatmentcycle. After completion of the treatment cycle, the second arm 204 isreturned to the first position for removal of the orthosis 200.

FIGS. 24-26 further illustrate several aspects of the invention moreconcretely. An orthosis 220 of the present invention includes a firstmember 221 having a first cuff 222 attachable to a user's foot and asecond member 223 having a second cuff 224 attachable to a toe of theuser's foot, wherein the second member 223 is rotatable with respect tothe first member 221 about an axis of rotation 226. The first and secondmembers 221 and 223 are attached to the foot and toe of the user withthe first and second cuffs 222 and 224, such that as the second member223 is rotated about the axis of rotation 226, the toe is rotated abouta joint axis.

A first extension member 228 is affixed to and extends from the firstmember 221, wherein a drive assembly 230 is positioned on an end portionof the first extension member 228. A second extension member 232 issimilarly affixed to and extends from the second member 223, wherein thesecond extension member 232 has an arcuate shape. The second extensionmember 232 engages the drive assembly 230 of the first extension member228 at a point “P.” An actuation of the drive assembly 230 operates tomove the second extension member 232 through the drive assembly 230,such that the second cuff 224 travels along an arcuate path “A” withrespect to the first member 221. The arcuate shape of the secondextension member 232 results in the toe rotating about the joint axis,as the second cuff 224 is moved along the arcuate path “A.” The driveassembly 230 can be actuated to move the second cuff 224 and toe from afirst position to a second position relative to the first cuff 222. Onceagain, the term “cuff” as used herein means any suitable structure fortransmitting the force of the orthosis 220 to the limb portion itengages.

The first extension member 228 can extend substantially vertically fromthe first member 221 or extend at an angle α from the first member 221,where the angle α and the radius of curvature of the second extensionmember 232 (if constant) can be configured such that of the axis ofrotation 226 is aligned with the joint axis of ration. As previouslydiscussed, the curvature of the second extension member 232 need not beconstant, and therefore the axis of rotation may shift or move in amanner that preferably mimics or approximates the moving IAR the jointwould normally have. Another potential benefit of the orthosis 220having the capability of a moving IAR is when multiple joints are beingtreated by the device. For instance, the range of motion of the tip of atoe or finger may involve cooperative motion of two or more joints. Ifthe combined bending of the multiple joints causes the overall motion torotation about a moving axis, it would be beneficial for the orthosis toapproximate this moving IAR. Thus, the curvature of the second extensionmember 232 may be complex in order to better approximate a moving IAR.

Referring to FIG. 27, the drive assembly 230 can include a housing 240having a worm gear 242 therein. A first miter gear 244 is attached tothe worm gear 242 such that a rotation of the first miter gear 244rotates the worm gear 242. The drive assembly 230 further includes adrive shaft 246 have a knob 248 at one end and a second miter gear 250at an opposite end. The second miter gear 250 is positioned within thehousing 240, in engagement with the first miter gear 244. A rotation ofthe knob 248 rotates the drive shaft 246 and the second miter gear 250,which in turn rotates the first miter gear 244 and the worm gear 242.

A gear surface 252 of the second extension member 232 includes aplurality of teeth 254. The second extension member 232 is positionedthroughout the housing 240, such that the worm gear 242 engages theteeth 254 of the second extension member 232. A rotation of the knob 248rotates the worm gear 242, which in turn moves the second extensionmember 232 through the housing 240.

In an alternative embodiment, the drive assembly 230 for orthosis 230 inaccordance with the present invention can be actuated by a motor insteadof by a manually actuatable member, such as the knob 248. Likewise, themotor may be configured an adapted with gearing that causes the orthosisto cycle through a range of motion in a predetermined manner, oralternatively maybe controlled by a programmable logic controller (PLC).

In an embodiment, an electric motor is mounted to the drive shaft 246for rotation of the second miter gear 250. A battery or other source ofenergy provides electric power to the motor. Alternatively, the motorcan be supplied with external power. A microprocessor controls theoperation of the motor. The microprocessor and motor together can beused to cycle the second cuff 34 through a plurality of positions thatcause the joint to undergo a range of motion, either by extension, byflexion, or both. For example, the microprocessor may be used to movethe second cuff 34 in one pivotal direction a certain amount, hold therewhile tissue stretches, then move further in that direction; or in anyother manner.

In another manner of use, the orthosis can be set to cycle to one end ofthe joint's range of motion and hold there for a predetermined period oftime, then cycle to the other end of the joint's range of motion andhold there. The programming and control of the microprocessor is withinthe skill of the art as it relates to driving the motor to control thesecond cuff 34 to move in known manners. This embodiment is ideallysuited for continuous passive motion exercise, because the orthosis isportable and because the motor can be programmed with the desiredsequence of movements.

It should be understood that the particular physical arrangement of themotor, the power source, and the microprocessor is not the only possiblearrangement of those elements. The invention contemplates that otherarrangements of these or similarly functional elements are quitesuitable, and thus, the invention is intended to cover any sucharrangement. Additionally, another type of power source, other than anelectric motor, can also be used. For example, the use of a hydraulic orpneumatic motor as the drive mechanism is contemplated.

The present invention can further include a monitor for use with theorthosis 220, which provides assurances the patient is properly usingthe orthosis 220 during his/her exercise period. For instance, themonitor can have a position sensor, a temperature sensor, a forcesensor, a clock or timer, or a device type sensor for monitoring thepatient's implementation of a protocol. The information obtained fromthese monitoring devices may be stored for later analysis orconfirmation of proper use or may be transmitted in real-time during useof the device. The data obtained from the monitor can be analyzed by ahealthcare professional or technician and the protocol can be adjustedaccordingly.

This analysis may be conducted remotely, thereby saving the time andexpense of a home visit by a healthcare professional or technician. Anexemplary monitoring system is provided in U.S. Publication No.20040215111 entitled “Patient Monitoring Apparatus and Method forOrthosis and Other Devices,” to Bonutti et al., the content of which isherein expressly incorporated by reference in its entirety.

In an exemplary use, the orthosis 220 is operated to rotate a toe abouta joint axis in the following manner. The first cuff 222 is fastenedabout the foot with one or more straps, laces, or similar retainingdevice. Similarly, the second cuff 224 is fastened securely to the toeof the user, such that the joint and joint axis 226 is interposedbetween the first and second cuffs 222 and 224. The orthosis 220 isattached to the foot and toe in a first position. The drive assembly 230is actuated to move the second extension member 232, such that thesecond cuff 224 travels along an arcuate path from the first position toa second position, relative to the first cuff 222, rotating the toeabout the joint axis stretching the joint. The orthosis 220 ismaintained in the second position for a predetermined treatment timeproviding a constant stretch to the joint. After the expiration of thetreatment time, the second cuff 224 is moved back to the first position,relieving the joint. Optionally, the second cuff 224 can be rotated to athird position, thereby increasing or decreasing the stretch on thejoint. The second cuff 224 can be rotated at discrete time intervals toincrementally increase the stretch of the joint through the treatmentcycle. After completion of the treatment cycle, the second arm member isreturned to the first position for removal of the orthosis 220.

Referring to FIG. 28, the second member 223 can include an attachmentbracket 260 for adjustably attaching the second cuff 224 to the secondextension member 232. The attachment bracket 260 can include a toe rod262 extending therefrom. The second cuff 224 can be slideably mounted onthe toe rod 262 to position second cuff 224 over the toe. Alternatively,the toe rod 262 can be of sufficient length such that the second cuff 24can be slidingly positioned on a selected toe on the foot of the user,for example, the big toe, minimus toe, or any toe therebetween.

The second cuff 224 can be positioned on the toe rod 262 with a firstbracket 264, where the toe rod 262 passes through a passage 266 in thefirst bracket 264. A set screw 268 is provided to secure the firstbracket 264 to the toe rod 262. When the set screw 268 is loosened, thefirst bracket 264 is free to slide along the toe rod 262. A tighteningof the set screw 268 secures the first bracket 264 in place on the toerod 272.

The second cuff 224 can further include a second bracket 270, where thesecond bracket 270 can be pivotally mounted to the first bracket 264.For example, the second bracket 270 can be attached to the first bracket264 with a pin or screw connector, allowing the second bracket 270 torotate with respect to the first bracket 264.

Additionally, when a joint is flexed or extended a compressive force maybe applied to the connective tissue surrounding the joint. It may bedesirable to control the compressive force, distracting the joint as thejoint is flexed or extended. “Distraction” is defined by one dictionaryas “Separation of the surfaces of a joint by extension without injury ordislocation of the parts.” (Taber's Cyclopedic Medical Dictionary, 16thEdition, 1989, page 521), and involves stretching rather thancompressing the joint capsule, soft tissue, ligaments, and tendons.

Additionally, the second bracket 270 can be slideably mounted to thefirst bracket 264. For example the second bracket 270 can be mounted tothe first bracket 264 with a dovetail joint 272, allowing the secondbracket 270 to slide with respect to the first bracket 264. The slidingmovement of the second cuff 224 helps to limit the distractive orcompressive forces which can be imparted on the joint by the rotation ofthe second cuff 224 with respect to the first cuff 222.

The attachment bracket 260 can be pivotally mounted to the secondextension member 232. For example, the attachment bracket 260 can beattached to the second extension member 232 with a pin or screwconnector 274, allowing the attachment bracket 260 to rotate withrespect to the second extension member 232. The second extension member232 further includes an extension bracket 276 having a slotted portion278. A set screw 280 is positionable through the slotted portion 278,engaging the attachment bracket 260, such that the set screw 280 can beused to control the pivotal position of the attachment bracket 260 withrespect to the second extension member 232.

The adjustable connection of the second cuff 224 to the attachmentbracket 260 and the pivotal connection of the attachment bracket 260 tothe second extension member 232 can be used to align the second cuff 224with the toe. The alignment of the second cuff 224 on the toe can beused to substantially limit the force applied to the toe to that of atorque about the joint axis 226.

Bending a Joint in Extension:

In operation of the orthosis 220 to extend the joint, the orthosisstarts at a more flexed position. The first and second cuffs 222 and 224are clamped onto the foot and toe portions, respectively, by straps 234,tightly enough so that the first and second members 221 and 223 canapply torque to extend the joint. The second extension member 232 ismoved through the drive assembly 230 from the first position to a secondposition, relative to the first extension member 228, rotating thesecond cuff 224 and the toe about the orthosis axis 226 stretching thejoint. As the second cuff 224 is rotated to the second position thesecond extension member 232 travels along an arcuate path “A” about andsubstantially through point “P.” The orthosis 220 is maintained in thesecond position for a predetermined treatment time providing a constantstretch to the joint.

As the orthosis 220 is rotated from the first position to the secondposition, extending the joint, the second cuff 224 moves along the firstbracket 64. Because the first and second members 221 and 223 are clampedonto the foot and toe as described above, the outward pivoting movementof the second cuff 224 causes the joint to be extended as desired.However, this extension of the joint can place strong distractive forceson the soft tissues around the joint. The sliding movement of the secondcuff 224 helps to limit these distractive forces by counteracting theoutward movement. Thus, the detrimental effects of strong distractiveforces normally generated in forced extension of a joint are avoided,being replaced with the beneficial effects of limited and controlleddistraction.

Bending a Joint Flexion:

In operation of the orthosis 220 to flex the joint, the orthosis 220starts at a more extended position. The first and second cuffs 222 and224 are clamped onto the foot and toe portions, respectively, by straps234, tightly enough so that the first and second members 221 and 223 canapply torque to extend the joint. The second extension member 232 ismoved through the drive assembly 230 from the first position to a secondposition, relative to the first extension member 228, rotating thesecond cuff 224 and the toe about the orthosis axis 26 stretching thejoint. As the second cuff 224 is rotated to the second position thesecond extension member 232 travels along an arcuate path “A” about andsubstantially through point “P.” The orthosis 220 is maintained in thesecond position for a predetermined treatment time providing a constantstretch to the joint.

As the orthosis 220 is rotated from the first position to the secondposition, flexing the joint, the second cuff 224 moves along the firstbracket 264. Because the first and second members 221 and 223 areclamped onto the foot and toe as described above, the inward pivotingmovement of the second cuff 224 causes the joint to be flexed asdesired. However, this flexion of the joint can place strong compressiveforces on the soft tissues around the joint. The sliding movement of thesecond cuff 224 helps to limit these compressive forces by counteractingthe inward movement. Thus, the detrimental effects of strong compressiveforces normally generated in forced flexion of a joint are avoided,being replaced with the beneficial effects of limited and controlledcompression.

Referring to FIG. 29, the drive assembly 230 can be adjustable mountedto the first extension member 228. The first extension member 228includes a longitudinal slotted section 282. A threaded member 284 ispositioned through the longitudinal slotted section 282, where thethreaded member 284 is threaded into a threaded hole 286 in the driveassembly 230. The position of the drive assembly 230 is secured on thefirst extension member 228 by tightening the threaded member 284,compressing the first extension member 228 between the threaded member284 and the drive assembly 230. The position of the drive assembly 230can be adjusted by loosening the threaded member 284 and sliding thedrive assembly 230 along the longitudinal slot 282. In this manner theposition of the drive assembly 230 can be adjusted to align the axis ofrotation 226 with the joint axis.

The drive assembly 220 can further include an indented portion 288. Theindented portion 288 in sized to receive the first extension member 228therein, such that the first extension member 228 slides through theindented portion 288 as the drive assembly 230 is moved along the firstextension member 230. The indented portion 288 is configured to alignthe drive assembly 230 with respect to the first extension member 228.The indented portion 288 provides the further benefit of resisting arotation of the drive assembly 230 with respect to the first extensionmember 228 when the orthosis 220 is in use.

Referring to FIG. 30, the drive assembly 230 can include a pair ofindented portions 288 and 290, positioned on opposite sides on the driveassembly 230. As shown in FIG. 29, the first indented section 288 can beused to position the drive assembly 230 in an outer position on theorthosis 220, where the drive assembly 230 is positioned on an outsidesurface 292 of the first extension member 228.

Alternatively, as shown in FIG. 31, the second indented section 290 canbe used to position the drive assembly 230 in an inner position on theorthosis 220, where the drive assembly 230 is positioned on an innersurface 294 of the first extension member 228. The threaded member 284is positioned through the longitudinal slotted section 282, where thethreaded member 284 is threaded into a second threaded hole 296 in thedrive assembly 230.

In an embodiment, the first member 221 can be adjustable mounted to thefirst cuff 222, such that the position of the second cuff 224 can beadjusted to align the second cuff 224 with a toe of interest and thejoint axis of the toe. In instances where the joint of a toe ismisaligned, for example for toe deformations such as hammer toe, bunion,etc., the linear and angular position of the second cuff 224 can beadjusted with respect to the first cuff 222 aligning the second cuff 224with the misaligned toe such that the axis of rotation 226 of theorthosis 220 is aligned with the axis of rotation of the toe joint. Inthe manner, the orthosis 220 can be adjusted to prevent the unwantedapplication of torsional forces to the toe joint.

Referring to FIG. 32, the first member 221 is adjustably attached to abottom surface of the first cuff 222. The first member 221 can includeda longitudinal slot. 300, through which a pair of threaded members 302and 304 are positioned, attaching the first member 221 to the first cuff222. The first member 221 can be moved along the longitudinal slot 300to laterally adjust the position of the first member 221 with respect tothe first cuff 222. The first member 221 is secured in position bytightening the threaded member 302 and 304, compressing the first member221 between the threaded members 302 and 304 and the bottom surface 298of the first cuff 222.

The first member 221 can further include a second longitudinal slot 306,parallel and offset from the first longitudinal slot 300. The firstmember 221 can be attached to the first cuff 222, using the secondlongitudinal slot 306 to longitudinally adjust the position of the firstmember 221 with respect to the first cuff 222. Similarly, the firstmember 221 can be moved along the second longitudinal slot 306 tolaterally adjust the position of the first member 221 with respect tothe first cuff 222.

It is also contemplated that the angular position of the first member221 can be adjusted with respect to the first cuff 222. In anembodiment, as shown in FIG. 33, the bottom surface 298 of the firstcuff 222 includes a center threaded hole 308 and an arcuate slot 310. Aninternally threaded fastener 312 is slidingly positioned in the arcuateslot 310, opposite the bottom surface 298. The first member 221 isattached to the first cuff 222 by positioning the threaded members 302and 304 through a longitudinal slot 300 or 306 of the first member 221and engaging the threaded hole 308 and the internally threaded fastener312 in the arcuate slot 310. The angular position of the first member221 can be adjusted with respect to the first cuff 222 by pivoting thefirst member 221 about threaded member 302 in the center threaded hole308, such that the internally threaded fastener 312 and the secondthreaded member 302 travel along the arcuate slot 310. The first member221 is secured in position by tightening the threaded members 302 and304, compressing the first member 221 between the threaded members 302and the bottom surface 298 of the first cuff 222, and compressing thefirst member 221 and first cuff 222 between threaded member 304 andinternally threaded fastener 312.

The bottom surface 298 of the first cuff 222 can further include asecond arcuate slot 314, where an internally threaded fastener 316 isslidingly positioned in the second arcuate slot 314, opposite the bottomsurface 298 of the first cuff 222. Similar to arcuate slot 310, secondarcuate slot 314 can be used to angularly adjust the position of thefirst member 221 with respect to the first cuff 222.

Specifically, the first member 221 is attached to the first cuff 222 bypositioning the threaded members 302 and 304 through a longitudinal slot300 or 306 of the first member 221 and engaging the threaded hole 308and the internally threaded fastener 316 in arcuate slot 314. Theangular position of the first member 221 can be adjusted with respect tothe first cuff 222 by pivoting the first member 221 about threadedmember 302 in the center threaded hole 308, such that the internallythreaded fastener 316 and the second threaded member 304 travel alongthe arcuate slot 314. The first member 221 is secured in position bytightening the threaded member 302 and 304, compressing the first member221 between the threaded members 302 and the bottom surface 298 of thefirst cuff 222, and compressing the first member 221 and first cuff 222between the threaded member 304 and internally threaded fastener 316.

It is also contemplated that the first member 221 can be attached to thefirst cuff 221 using the arcuate slots 310 and 314 and the respectedinternally threaded members 312 and 316. Specifically, the first member221 is attached to the first cuff 222 by positioning the threadedmembers 302 and 304 through a longitudinal slot 300 or 306 of the firstmember 221 and engaging the internally threaded fastener 312 in thearcuate slot 310 and the internally threaded fastener 316 in arcuateslot 314. The angular position of the first member 221 can be adjustedwith respect to the first cuff 222 by pivoting the first member 221 suchthat the internally threaded fasteners 312 and 316 travel along thearcuate slots 310 and 314. The first member 221 is secured in positionby tightening the threaded member 302 and 304, the first member 221 andfirst cuff 222 between the treaded members 302 and 304 and internallythreaded fastener 312 and 316.

While the embodiment discussed above utilize a second extension memberhaving an arcuate shape to control movement of the second memberrelative to the first, it should be understood that skilled artisanshaving the benefit of this disclosure will appreciate that otherconfigurations may likewise provide similar relative movement.

FIG. 34, for example, schematically illustrates an embodiment of anorthosis 330 of the invention having a first member 332 and a secondmember 334, both of which preferably having sufficient structure orcomponent parts to hold body members near the treated joint or joints.In the embodiment illustrated in FIG. 34 the second member has a firstpivoting contact point 336 about which the geared body member mayrotate. In this embodiment, the first pivoting contact 336 does not movein relation to the first body member 330, but as indicated in FIG. 32one alternative embodiment may allow relative movement that can beresisted by a flexible device 338 such as a spring, compressed gas,foamed material, elastomer or the like.

Returning once again to FIG. 34, the second member may have anadditional pivot contact 340, preferably disposed at a location at ornear the opposite end of the second member 334 from where the firstpivoting contact 336 is located. The second pivoting contact 340 may beconfigured with a drive assembly 344 that causes the second member 334to follow a predetermined path. Thus, the second pivoting contact 340 inthe embodiment of FIG. 34 is configured to move relative to the firstmember 332 in order to cause the joint to move from a first position tosecond one.

The drive assembly 344 illustrated in FIG. 34 is an arm or linkage 346connected between the second pivot connection 340 and a rotating wheel348. The wheel 348 may be configured so that the linkage 346 can beselectively connected to it in different radial distances from thecenter of rotation of the wheel. This allows the range of motion to beadjustable by the care provider, physician, or patient. As the wheel 348is rotated, the linkage 346 moves in a manner that causes the secondmember 334 to move in a particular way.

The second member 334 (or alternatively the first member 332) may alsohave a sliding contact surface 342. The sliding contact surface 342allows the joint to rotate or move according to its naturalinstantaneous axis of rotation. Thus, if the second pivot contact 340moves in a manner that does not always exactly correspond to the axis ofrotation of the joint, the sliding contact surface 342 may move oradjust accordingly. Another potential advantage of the sliding contactsurface 342 is that it may help facilitate proper alignment of the jointin the orthosis during initial setup.

FIG. 34 illustrates some variations that may also be used in orthosis ofthe invention. For instance, the first and or second pivot contact maybe configured with a cushion or spring 338 that allows one or both endsof the second member to impart some flexibility in the force imparted tothe joint. As noted above, the cushion or spring 338 may be made of avariety of suitable materials and constructions to permit someflexibility in the movement of the pivot points 336, 340.

The use of a spring or cushion allows the orthosis 330 to be used indifferent treatment protocols than just by holding the joint in aprescribed location for a period of time. Instead, the orthosis canutilize the principles of static progressive stretch as described incopending application Ser. No. 11/203,516, entitled “Range of MotionSystem and Method”, and filed on Aug. 12, 2005, the entirety of which isincorporated by reference.

Thus, an orthosis 330 configured with a spring or cushion 338 can bemoved from an initial position to a second position that is determinednot by position of the joint but instead by the amount of force theorthosis 330 imparts on the joint. The joint may then be subjected tothis loading, and over time as the surrounding tissue stretches thejoint will move and the imparted forces will be reduced. It should benoted that while FIG. 35 illustrates the cushion or spring 338associated with the first pivot contact 336, it is not required to beassociated with it. Instead, for example, the cushion or spring 338 maybe associated with the second pivot 340 so that it can flex or move inresponse to resistive forces of the joint and nearby tissue. Likewise,there may be a spring or cushion 338 associated with both pivot contacts336, 340.

Another notable variation between the embodiments of FIGS. 34 and 35 isthat the rotating wheel 348 in FIG. 34 has multiple single pointconnections for connecting the linkage 346 at different distances fromthe center of rotation of the wheel. In contrast, the embodiment of FIG.35 illustrates that an elongated slot 350 may be used to connect thelinkage 346. The advantage of utilizing multiple single pointconnections may be ease of use and the ability to quickly confirm theorthosis 330 is properly configured for a prescribed treatment protocol,whereas one potential advantage of utilizing an elongated slot 350 isthe ability to quickly adjust the settings without disassembling thedevice.

FIG. 36 illustrates an embodiment of the invention where the rotatingwheel 348 is a cam surface 352. This embodiment is similar to the use ofcams and followers as described in U.S. Pat. No. 5,514,143, which isincorporated herein in its entirety. As shown, the cam surface 352 mayhave varying distance from the center or rotation of the wheel 348. Ifthe wheel 358 is circular, for example, the center of rotation may belocated somewhere different from the geometric center of the circle orat the center or rotation of the shape. As it rotates, thecircumferential outer surface causes the linkage 346 to move to thesecond member 340 in a desired manner. Additionally, the outer edge ofthe “wheel” 348 need not be round, but instead may be a cam surface 352of varying distance from the center or rotation. Likewise, the outersurface may have varying radii of curvature as shown in FIG. 36.

The embodiments of FIGS. 37 and 38 further illustrate that a cam surface352 may be used to move the second member 332 in a desired, perhapscomplex way. As is the case for other embodiments described herein,performance of the cam surface 352 may be enhanced because of theability to better mimic or replicate a moving axis of rotation of thetreated tissue and joint.

In FIG. 37, the cam surface 352 is associated with the first member 332.Linkages or arms 346 of the second member 334 have cam followers 354that trace the cam surface 352 and cause the second member 334 to movein a more complex manner than just by rotation around a fixed axis.

The cam surface 352 of FIG. 37 also is associated with a slot 356 thatallows the relative location of the first and second members 332 and 334to be adjusted or moved without decoupling the cam followers 354 fromthe cam surface 352. As shown, the slot 356 allows for horizontaladjustment repositioning. Although not shown, vertical slots may also beprovided, either alone or in combination with a horizontal slot.

FIG. 38 illustrates an example where the linkage 346 is a cam surface352 that passes through two or more points 358, 360 that are stationaryor fixed relative to the first member 332 when the orthosis 330 is inuse (i.e. after alignment is completed). Once again, this embodiment maybe configured to permit horizontal adjustment, such as by providing slot368, and likewise may be configured to be vertically adjustable. Inaddition, this embodiment also illustrates that the first and secondmembers 332 and 334 may be represented by rotation about a pivot 370.Thus, the use of horizontal, vertical, and rotational adjustment of therelative positions of the first and second members 332 and 334 may allowgreater fitting of the orthosis 330 to the treated tissue and joint.

FIG. 39 is an exploded view of how the cam surface 352 and cam followers354 may utilize a geared surface 372. Utilizing a geared surface 372 mayallow for a drive assembly 344 to automate the movement of the orthosis330.

FIGS. 40 and 41 schematically illustrate other ways in which potentiallycomplex movement of the second member 334 may be controlled. FIG. 40illustrates that the cam surface may not be directly formed from acomponent part of either the first or second members, but instead maybeassociated with some other structure. For instance, the orthosis 330 maybe operatively connected to a base unit 374 having a plurality of camsurfaces 376 corresponding to different ranges of motion for relatedjoints, such as when the orthosis 330 can be used to treat a pluralityof different toes or a patient. Once the orthosis 181 is placed on thepatient, the second member 334 will be positioned to securely hold oneof the toes on the patient's foot and to engage with the cam surface 376corresponding to that toe.

FIG. 41 shows that multiple cam surfaces or slots 378 may be formed in aside panel 380. The side panel 380 may have a sliding engagement of thesecond member 334. As the second member 334 moves, the engagement withthe side panel 380 controls position and movement. Moreover, one or moresides or edges of a slot 316 of the embodiment of FIG. 41 may be gearedto allow implementation of a drive assembly 344.

FIG. 42 illustrates an embodiment where movement of at least part of alinkage 346 may be linear, but when combined with a rotational pivot382, sliding slot 384, and possibly other components or combinationsdescribed herein, the net effect on the second member 334 is once againa controlled movement in a desired manner.

The components of the present invention are rigid members made of, forexample, aluminum, stainless steel, polymeric, or composite materials.The member and extensions are sufficiently rigid to transmit thenecessary forces. It should be understood that any material ofsufficient rigidity might be used. For example, some components can bemade by injection molding. Generally, for injection molding, tool anddie metal molds of the components are prepared. Hot, melted plasticmaterial is injected into the molds. The plastic is allowed to cool,forming components. The components are removed from the molds andassembled.

Furthermore, it is contemplated that the components can be made ofpolymeric or composite materials such that the device can be disposable.For example, at least some or all of the components can be made of abiodegradable material such as a biodegradable polymer. Among theimportant properties of these polymers are their tendency todepolymerize relatively easily and their ability to form environmentallybenign byproducts when degraded or depolymerized. One such biodegradablematerial is poly (hydroxyacids) (“PHA's”) such as polyactic acid (“PLA”)and polyglycolic acid (“PGA”).

Additionally, the device can be made of a nonmagnetic material. In suchinstance, the device can be used as a positioning device for use inimaging devices, such as a MM device. It is also contemplated that thedevice can be used as a positioning device for use during surgicalprocedures, where it may be necessary to adjust and hold the position ofthe joint.

In a method of manufacture, the cuffs can include a base plate having aplurality a strap attached thereto, where the straps are position abouta body portion of a patient. The straps are attached to the base plateusing fastener elements, such as screws threaded into the base plate.The screws can be removable to allow for easy removal and/or replacementof the straps.

Alternatively, in an embodiment where the base plate is made of apolymeric material, the straps can be welded to the base plate using anenergy welding technique such as, RF welding, ultra-sonic welding, highfrequency welding, etc. For example, in ultra-sonic welding an acoustictool in used to transfer vibrational energy into the weld areas of thestraps and the base plate. The friction of the vibrating moleculesgenerates heat, which melts the surface material of the base plate inthe welding area, at which point the vibrational energy is stopped.Pressure is applied to the strap and the base plate, allowing the meltedmaterial to solidify within the material of the strap. In this methodthe strap is secured to the base plate without the need of fasteners.

Similarly, where the cuffs are made of a polymeric material, the cuffcan be welded to the orthosis using energy welding techniques. Forexample, the cuffs can be made of a substantially rigid, flexible, orfabric polymeric material which can be welded directly onto the armmembers of the orthosis. It is also contemplated that the straps can bean integral part of the cuffs. For example, where the cuffs are made ofa polymeric fabric, the straps can be integrally formed in the fabricpattern when making the cuffs.

All references cited herein are expressly incorporated by reference intheir entirety.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. For example, although the examples presentedidentify the toe joint, the present invention can be used for any jointin the body of the patient. In addition, unless mention was made aboveto the contrary, it should be noted that not all of the accompanyingdrawings are to scale. A variety of modifications and variations arepossible in light of the above teachings without departing from thescope and spirit of the invention, which is limited only by thefollowing claims.

What is claimed:
 1. A device for moving a knee joint in a body of apatient, the device comprising: a first arm member coupled to a firstleg support configured to support an upper portion of a leg of thepatient; a second arm member coupled to a second leg support configuredto support at least one of a lower portion of a leg and a foot of thepatient; a control assembly operatively connected to the first andsecond arm members and configured to selectively move the second armmember relative to the first arm member, the control assemblycomprising: a first motorized drive assembly coupled to the first andsecond arm members and operable to drive movement of the second armmember relative to the first arm member; and a second motorized driveassembly coupled to the first and second arm members and operable todrive movement of the second arm member relative to the first armmember.
 2. The device for moving a knee joint in a body of a patient asset forth in claim 1, wherein the first and second motorized driveassemblies include at least one of a hydraulic and pneumatic motor. 3.The device for moving a knee joint in a body of a patient as set forthin claim 1, further comprising a monitor having a storage medium, themonitor configured to track and store usage information of the device.4. The device for moving a knee joint in a body of a patient as setforth in claim 3, wherein the monitor further comprises a display fordisplaying positional information of the device.
 5. The device formoving a knee joint in a body of a patient as set forth in claim 3,wherein the monitor further comprises a data transfer component forwirelessly transferring usage information of the device.
 6. The devicefor moving a knee joint in a body of a patient as set forth in claim 1,further comprising a locking mechanism configured to prevent actuationof at least one of the first motorized drive assembly and the secondmotorized drive assembly.
 7. The device for moving a knee joint in abody of a patient as set forth in claim 1, further comprising a lowerleg strap for securing at least one of the lower portion of a leg andthe foot of the patient to the second leg support.
 8. The device formoving a knee joint in a body of a patient as set forth in claim 1,further comprising an upper leg strap for securing an upper portion of aleg of the patient to the first leg support.
 9. The device for moving aknee joint in a body of a patient as set forth in claim 1, furthercomprising a timer.
 10. The device for moving a knee joint in a body ofa patient as set forth in claim 1, wherein the second drive assembly isconfigured to move the second arm member to at least one of increase anddecrease a force exerted by the device.
 11. The device for moving a kneejoint in a body of a patient as set forth in claim 1, wherein the firstmotorized drive assembly includes a drive element configured toselectively move the second arm member while the second motorized driveassembly is maintained in a fixed position relative to the first andsecond arm members.
 12. The device for moving a knee joint in a body ofa patient as set forth in claim 1, wherein the second motorized driveassembly includes a drive element configured to selectively move thesecond arm member while the first motorized drive assembly is maintainedin a fixed position relative to the first and second arm members. 13.The device for moving a knee joint in a body of a patient as set forthin claim 1, wherein the second arm member further comprises atelescoping member for adjusting the length of the second arm member.14. A device for moving a leg of a user into flexion and extension, thedevice comprising: a base member; a first arm member coupled to the basemember; a second arm member coupled the first arm member; a motorizeddrive assembly mounted to the base member and pivotably coupled to thesecond arm member, the drive assembly configured to selectively move thesecond arm member relative to the first arm member; and a lockingmechanism coupled to at least one of the first and second arm members,the locking mechanism configured to prevent actuation of the firstmotorized drive assembly.
 15. The device for moving a leg of a user intoflexion and extension as set forth in claim 15, wherein the first armmember is coupled to a first leg support configured to support an upperportion of the leg and the second arm member is coupled to a second legsupport configured to support at least one of a lower portion of the legand a foot.
 16. The device for moving a leg of a user into flexion andextension as set forth in claim 15, further comprising a controllerconfigured to enable a user to selectively move the second arm member toallow for angle control of the first and second arm members.
 17. Thedevice for moving a leg of a user into flexion and extension as setforth in claim 15, wherein the drive assembly enables incrementalmovement of the device to move the leg of a user.
 18. The device formoving a leg of a user into flexion and extension as set forth in claim15, further comprising a monitor having a storage medium, the monitorconfigured to track and store usage information of the device.
 19. Thedevice for moving a leg of a user into flexion and extension as setforth in claim 18, wherein the monitor further comprises a data transfercomponent for wirelessly transferring usage information of the device20. The device for moving a leg of a user into flexion and extension asset forth in claim 18, wherein the monitor further comprises a displayfor displaying degrees of at least one of flexion and extension.